Cleared Traditional

K950779 - HEART RATE VARIABILITY SOFTWARE OPTION

K950779 is an FDA 510(k) clearance for HEART RATE VARIABILITY SOFTWARE OPTION, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K950779 · Spacelabs, Inc. · Cardiovascular device
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Apr 1995
Decision
63d
Days
Class 2
Risk

K950779 is an FDA 510(k) clearance for the HEART RATE VARIABILITY SOFTWARE OPTION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spacelabs, Inc. devices

FDA 510(k) Submission Details - K950779

510(k) Number K950779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date April 25, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K950779.
HEWLETT-PACKARD MODEL M1264B CATHSTATION
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K935394 · Marquette Electronics, Inc. · Oct 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994